The legislation of Ukraine on the advertising of medicinal products should be brought in line with the European standards, in particular, with the provisions of Directive No. 2001/83/EC of 6 November 2001 on the scope of laws concerning medicines. This was underscored by MP Iryna Sysoyenko of the Samopomich faction, Deputy Head of the Verkhovna Rada Committee on Health.
On May 16 of this year, the Ministry of Health of Ukraine (the MH) published on the official website the draft Law of Ukraine “On Amendments to Certain Legislative Acts of Ukraine (on improving the procedure for advertising medicines)”, which proposes to introduce a new legislative regulation of drug advertising.
“I support such an initiative of the Ministry of Health and the innovations proposed by this bill, and I urge my fellow MPs, as well as medical experts and representatives of the media to participate in the discussion of it,” Iryna Sysoyenko suggested.
What innovations does the MH offer?
If the current version of the Law allows advertising only such medicines that are available without prescription and are not included in the list of drugs prohibited for advertising, now it will be allowed to advertise the medicines that are available without prescription and being available without prescription are not included in the list of drugs prohibited for advertising.
Similarly, changes are made regarding the prohibition of advertising of medical products, namely:
It is forbidden to advertise prescription medical products as well as those products included in the List of drugs that are available without prescription but prohibited for advertising.
The bill also stipulates that the list of medicines prohibited for advertising should be approved by the Ministry of Health. That is, the Ministry of Health has to draft and approve such a new List.
It is suggested that the text of the warning “Self-medication may be hazardous to your health” placed on the ads of medical products should include a reference to the number of the valid registration certificate, while the content of the ad should correspond to the information stated in the instruction for the use of such a drug.
In addition to this, it is proposed to exclude the following from the advertising of medicines, medical products and methods of prevention, diagnosis, treatment and rehabilitation:
– the information which offers to define a diagnosis or treatment course using telecommunications means;
– the information in which incorrect information about the onset of recovery is provided;
– the recommendations or references to the recommendations of individuals who can encourage the use of some medical products taking advantage of their popularity;
– the information that medicines, medical products, methods of prevention, diagnosis, treatment and rehabilitation are designed exclusively or mainly for children;
– advertising of alternative medicine (healing) services and persons who provide them is prohibited.
The bill establishes a list of professional scientific publications that publish advertising materials aimed at medical and pharmaceutical workers specifically, in which advertising of medicines, medical products and methods of prevention, diagnosis, treatment and rehabilitation, unforeseen by law, will be permitted.
In addition, the procedure for advertising medicines aimed at medical and pharmaceutical workers should be developed by the Ministry of Health and approved by the Cabinet of Ministers of Ukraine.
It will be the Ministry of Health that will monitor compliance with the legislation on advertising of medicines, medical equipment, methods of prevention, diagnosis, treatment and rehabilitation.
Penalties will be imposed on television and radio organizations – 5% of the license fee for violating legislation during the promotion of medicines, namely:
– for advertising prescription medicinal products or the medicines included in the List of drugs prohibited for advertising;
– for advertising doping substances and/or methods of their use in sports;
– for advertising healing for the mass audience;
– for advertising new methods of prevention, diagnosis, rehabilitation and medicines that are under consideration in an established manner, but are not yet permitted to be used;
– for advertising services of alternative medicine (healing) and persons who provide them.
Iryna Sysoyenko believes that people should be able to learn about new drugs, modern practices and methods of treatment, but the information that is provided in ads must be truthful and as specific as possible. She hopes that the discussion of the bill will not be delayed and we will be able to establish new clear rules for the advertising of medicines already during this parliamentary session.